FDA 483 - Curonix LLC - November 08, 2023

On November 8, 2023, the FDA issued a Form 483 to Curonix LLC, a medical device manufacturer located in Pompano Beach, FL, following an inspection conducted from October 18 to November 8, 2023. The inspection identified four observations related to the firm's quality system and manufacturing processes.

Observation 1 noted inadequate corrective and preventive action procedures. Curonix failed to determine all potential causes for a barcode label scanning nonconformity, where an incorrect expiration date was entered, leading to an invalid barcode. The investigation was closed without a comprehensive analysis of factors like label visual inspection procedures, personnel competency, barcode generating software capabilities, and in-process/final release label review.

Observation 2 highlighted deficiencies in procedures for receiving, reviewing, and evaluating complaints. Procedure WI-15-04 lacked clear instructions for complaint investigation codes, resulting in inappropriate use of "No Problem/Fault Found" even when product failures (e.g., eroded lead, broken antenna) were reported. Contradictory information was recorded in Device History Records, and the complaint procedure failed to require review of the complaint log for recurring issues with the same lot number, such as multiple "unable to scan label" complaints for lot SWO220726.

Observation 3 indicated that software used in production and the quality system was not adequately validated for its intended use. Non-product software lacked validation